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One Drop 8000-10495

by Informed Data Systems Inc.

One Drop 8000-10495 is a Class II device made by Informed Data Systems Inc., listed in FDA GUDID since 7 Apr 2017 (UDI-DI 00859509006026), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859509006026 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
One Drop
Generic name
Glucose monitoring system IVD, home-use
Model / reference
8000-10495
Primary DI / UDI-DI
00859509006026
FDA product code
NBW
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose monitoring system IVD, home-use

Other devices from Informed Data Systems Inc.

See all devices from Informed Data Systems Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (11, all answered No)